Gilead Sciences (GILD) announced that the FDA has accepted its New Drug Application submissions for lenacapavir-the twice-yearly injectable HIV-1 capsid inhibitor-for the prevention of HIV as pre-exposure prophylaxis. The FDA will review the applications under priority review and has assigned a PDUFA target action date of June 19, 2025. The NDAs are based on data from the Phase 3 PURPOSE 1 and PURPOSE 2 trials conducted by Gilead.
The company noted that the use of lenacapavir for the prevention of HIV is investigational and is not approved anywhere globally.
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